alvimopan

Generic: alvimopan

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alvimopan
Generic Name alvimopan
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

alvimopan 12 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 0254-3012
Product ID 0254-3012_dfefc7c5-f78e-4732-868b-0d6b4dfdef52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216843
Listing Expiration 2026-12-31
Marketing Start 2023-05-03

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02543012
Hyphenated Format 0254-3012

Supplemental Identifiers

RxCUI
799835
UPC
0302543012558
UNII
677C126AET

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alvimopan (source: ndc)
Generic Name alvimopan (source: ndc)
Application Number ANDA216843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0254-3012-55 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK

Ingredients (1)

alvimopan (12 mg/1)

Linked Drug Pages (1)

ALVIMOPAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dfefc7c5-f78e-4732-868b-0d6b4dfdef52", "openfda": {"upc": ["0302543012558"], "unii": ["677C126AET"], "rxcui": ["799835"], "spl_set_id": ["1cd584de-b704-4d26-8451-e3247ffb8d08"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (0254-3012-55)  / 5 CAPSULE in 1 BLISTER PACK", "package_ndc": "0254-3012-55", "marketing_start_date": "20230503"}], "brand_name": "ALVIMOPAN", "product_id": "0254-3012_dfefc7c5-f78e-4732-868b-0d6b4dfdef52", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0254-3012", "generic_name": "ALVIMOPAN", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALVIMOPAN", "active_ingredients": [{"name": "ALVIMOPAN", "strength": "12 mg/1"}], "application_number": "ANDA216843", "marketing_category": "ANDA", "marketing_start_date": "20230503", "listing_expiration_date": "20261231"}